FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE SKIN MARKING PEN
K Number: K843116
·
Decision Aug 17, 1984
Classifications
1
FEI Numbers
183
Registration Numbers
184
Same Product Code
22
Applicant Total
21
Review Days
9
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DISPOSABLE SKIN MARKING PEN
- K Number
- K843116
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4660
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- E.M. Adams
- Date Received
- August 8, 1984
- Decision Date
- August 17, 1984
- Product Code
- FZZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FZZ | Marker, Skin | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FZZ), ordered by most recent decision date.
SURGICHIP TAG SURGICAL MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DISPOSABLE SKIN MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BLOOM TRANSPARENT STENCIL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ROCKET SURGICAL SKIN MARKING PEN
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SKIN MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
QUALTEX SKIN MARKER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by E.M. Adams
| K Number | Device Name | ||
|---|---|---|---|
| K905173 | SPLASH GUARD | Apr 25, 1991 | Substantially Equivalent |
| K910468 | STERILE DISPOSABLE DRAPE(S) | Mar 21, 1991 | Substantially Equivalent |
| K873978 | DISPOSABLE BIPOLAR FORCEPS | Nov 23, 1987 | Substantially Equivalent |
| K850063 | INSTRUMENT POCKET | Feb 21, 1985 | Substantially Equivalent |
| K843724 | I.V. START KIT & OBSTETRICAL KIT | Jan 10, 1985 | Substantially Equivalent |
| K843783 | WET PACK | Dec 19, 1984 | Substantially Equivalent |
| K843782 | DRY TRAY | Dec 13, 1984 | Substantially Equivalent |
| K843723 | STERILE INSTRUMENT TRAYS-VARIOUS | Oct 23, 1984 | Substantially Equivalent |
| K843115 | STERILE SOLUTION BOWL | Sep 7, 1984 | Substantially Equivalent |
| K831841 | STERILE DISP. INSTRUMENT TRAYS | Dec 14, 1983 | Substantially Equivalent |